NCT06994819

Evaluation of the Niostem Headset for Hair Growth and Hair Quality

Double-blind Randomized Controlled Clinical Trial Under Dermatological Monitoring on Skin Tolerability and Efficacy of the Niostem Headset on Hair Growth, Hair Loss and Hair Quality After 3 and 6 Months of Daily Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Mane Biotech GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This double-blind, randomized, placebo-controlled clinical trial evaluates the Niostem headset, an electronic device designed to support hair growth, reduce hair loss, and improve hair quality. A total of 101 adult participants (20 female, 81 male) aged 18-55 were enrolled. Participants used the device daily for 30 minutes over a six-month period. The primary objective is to assess skin tolerability, and secondary objectives include evaluating usability and efficacy through validated questionnaires, TrichoScan hair analysis, and digital imaging under dermatological supervision.

Detailed description

The study is conducted by Dermatest GmbH from October 2023 to September 2024 under dermatological supervision. The Niostem headset is a home-use electronic device applied daily for 30 minutes following standardized protocols. The primary endpoint is skin tolerability, with secondary endpoints assessing usability and potential effects on hair quality and growth. Dermatological evaluations occur at baseline, 3 months, and 6 months. Quantitative assessments include TrichoScan imaging and digital macro photography, while subjective feedback is collected using validated self-report questionnaires. Participants are adults experiencing pattern hair loss-classified as Norwood stages 2-5 (men) and Ludwig stages I-II (women). Exclusion criteria include scalp conditions, pregnancy, ongoing medication use, and dermatological or psychiatric disorders. The study aims to assess the safety and user experience of a non-chemical, wearable neuromodulation device for cosmetic scalp and hair applications.

Conditions

• Androgenetic Alopecia
• Pattern Baldness

Interventions

Type	Name	Description
DEVICE	niostem headset (Active)	The niostem headset is a non-invasive electronic stimulation device designed to reduce hair loss and improve hair growth. It delivers low-level electrical stimulation through brush electrodes that contact the scalp. Used once daily for 30 minutes for 6 months. Sessions are guided via a smartphone app.
DEVICE	Sham niostem headset (Placebo)	he sham niostem headset is visually identical to the active device but does not deliver electrical stimulation. Used once daily for 30 minutes for 6 months. Allows for blinding and placebo-controlled comparison.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2025-05-29
• Last updated: 2025-06-22

Locations

1 site across 1 country: Germany